Supporting Quality and Environmental Management Across Zazyro’s Operations
CEB supported Zazyro Grup SRL and Zazyro Medical Services SRL through process assessment, management-system implementation, documentation development and preparation for independent certification across quality and environmental management.
The engagement contributed to three independently issued certificates: ISO 9001:2015 and ISO 14001:2015 for Zazyro Grup’s medical-device distribution and pharmaceutical wholesale activities, and ISO 9001:2015 for Zazyro Medical Services’ production, installation and commissioning of water-purification stations.
Zazyro Grup SRL and Zazyro Medical Services SRL
Medical, pharmaceutical and water treatment
Distribution and water-purification systems
Three certificates across Zazyro Grup and Zazyro Medical
ABOUT ZAZYRO
Zazyro operates through two Romanian companies serving complementary activities in the medical, pharmaceutical and water-treatment sectors.
Zazyro Grup SRL imports and distributes medical devices and conducts wholesale trade in pharmaceutical products. Zazyro Medical Services SRL produces, installs and commissions water-purification stations.
The engagement covered ISO 9001 and ISO 14001 management-system consultancy and certification preparation. The applicable requirements were ISO 9001:2015 and ISO 14001:2015.
The verified outcome was three management-system certificates across two legal entities.
Project objective
Zazyro sought to establish structured and auditable management systems suited to two companies with distinct operational scopes. The objective was to strengthen process consistency, clarify responsibilities, improve control of documented information and prepare both organizations for independent certification.
For Zazyro Group, the work addressed quality and environmental management across medical-device distribution and pharmaceutical wholesale. For Zazyro Medical Services, it focused on quality management throughout the production, installation and commissioning of water-purification stations.
The management systems were developed through a coordinated implementation process. Confidential information concerning internal procedures, business relationships and initial assessment findings is not disclosed in this case study.
Project objective
Zazyro sought to establish structured and auditable management systems suited to two companies with distinct operational scopes. The objective was to strengthen process consistency, clarify responsibilities, improve control of documented information and prepare both organizations for independent certification.
For Zazyro Grup, the work addressed quality and environmental management across medical-device distribution and pharmaceutical wholesale. For Zazyro Medical Services, it focused on quality management throughout the production, installation and commissioning of water-purification stations.
The management systems were developed through a coordinated implementation process. Confidential information concerning internal procedures, business relationships and initial assessment findings is not disclosed in this case study.
What CEB supported
ISO 9001 FOR ZAZYRO GRUP
Structuring quality processes for medical-device distribution and pharmaceutical wholesale operations.
ISO 14001 FOR ZAZYRO GRUP
Establishing environmental controls for medical-device distribution and pharmaceutical wholesale operations.
ISO 9001 FOR ZAZYRO MEDICAL SERVICES
Defining quality controls for water-purification station production, installation and commissioning.
Quality management for Zazyro Grup under ISO 9001
CEB supported Zazyro Grup in developing and implementing a quality management system aligned with ISO 9001:2015 for the import and distribution of medical devices and the wholesale of pharmaceutical products.
The work focused on translating the standard’s requirements into practical controls for consistent operations, clear responsibilities, controlled documentation and measurable quality objectives. The system was structured around the certified activity rather than treated as a generic set of procedures.
The implementation defined the system scope, mapped relevant processes, clarified responsibilities and process ownership, developed policies, procedures and records, established measurable quality objectives, and prepared the organization for internal review and independent certification.
CEB supported Zazyro Grup in developing and implementing a quality management system aligned with ISO 9001:2015 for the import and distribution of medical devices and the wholesale of pharmaceutical products.
The work focused on translating the standard’s requirements into practical controls for consistent operations, clear responsibilities, controlled documentation and measurable quality objectives. The system was structured around the certified activity rather than treated as a generic set of procedures.
The implementation defined the system scope, mapped relevant processes, clarified responsibilities and process ownership, developed policies, procedures and records, established measurable quality objectives, and prepared the organization for internal review and independent certification.
Assessing processes and management-system requirements
CEB reviewed the relevant operational and support processes, responsibilities, documents and records for both companies. Each certification scope was considered separately so that the management systems could reflect the activities, interfaces and risks associated with the relevant legal entity.
The work focused on translating the standard’s requirements into practical controls for consistent operations, clear responsibilities, controlled documentation and measurable quality objectives. The system was structured around the certified activity rather than treated as a generic set of procedures.
01Reviewing operational and support processes for both companies
02Examining responsibilities, documents and records
03Considering each legal entity and certification scope separately
04Assessing activities, interfaces and relevant operational risks
05Reviewing document control, objectives and assigned responsibilities
06Evaluating internal audits, corrective actions and management review
07Coordinating common principles across the engagement
01Reviewing operational and support processes for both companies
02Examining responsibilities, documents and records
03Considering each legal entity and certification scope separately
04Assessing activities, interfaces and relevant operational risks
05Reviewing document control, objectives and assigned responsibilities
06Evaluating internal audits, corrective actions and management review
07Coordinating common principles across the engagement
Environmental management for Zazyro Grup under ISO 14001
CEB also supported Zazyro Grup in establishing an environmental management system aligned with ISO 14001:2015 for the same certified scope: the import and distribution of medical devices and the wholesale of pharmaceutical products.
The implementation provided a structured way to identify environmental aspects, evaluate relevant obligations, define environmental objectives and establish operational controls.
It also connected environmental responsibilities with the company’s wider management and review processes. The work covered environmental-aspect evaluation, applicable compliance obligations, policy and objectives, operational controls, performance monitoring, internal audit, management review and preparation for independent assessment.
Zazyro Grup · ISO 9001
Import and distribution of medical devices; wholesale of pharmaceutical products.
Zazyro Grup · ISO 14001
Import and distribution of medical devices; wholesale of pharmaceutical products.
Zazyro Medical Services · ISO 9001
Production, installation and commissioning of water-purification stations.
Preparing for independent certification
CEB identified the applicable requirements and certification scope for each legal entity, assessed existing processes, responsibilities and documentation, and developed the required management-system documentation.
Policies, procedures and operational controls were implemented alongside personnel guidance, internal audits and management review. CEB then supported preparation for and assistance during the independent certification audits. Final decisions remained exclusively with the respective certification bodies.
Zazyro Grup · ISO 9001
Import and distribution of medical devices; wholesale of pharmaceutical products.
Zazyro Grup · ISO 14001
Import and distribution of medical devices; wholesale of pharmaceutical products.
Zazyro Medical Services · ISO 9001
Production, installation and commissioning of water-purification stations.
Quality management for Zazyro Medical Services under ISO 9001
For Zazyro Medical Services, CEB supported the implementation of a separate quality management system aligned with ISO 9001:2015. The certified scope covers the production, installation and commissioning of water-purification stations.
The work focused on building quality requirements into the complete delivery process, from production planning and controlled execution through installation, commissioning and the retention of relevant records. This helped create a consistent framework for responsibilities, process checks, nonconformity management and continual improvement.
The implementation included:
Defining the scope and process structure of the quality management system
Mapping production, installation and commissioning activities
Establishing responsibilities and operational control points
Developing procedures and records suited to the certified scope
Defining methods for monitoring performance and addressing nonconformities
Preparing the company for internal and independent audits
The final certification decisions remained exclusively with the respective independent certification bodies.
What Zazyro received
Management-system frameworks tailored to two legal entities and their distinct certified activities
Documentation tailored to medical-device, pharmaceutical and water-purification operations.
Clearly defined processes, responsibilities and operational controls
Quality and environmental objectives supported by monitoring and review arrangements
Practical guidance for implementation, audit preparation and the independent certification process
Three independently issued certificates: two ISO 9001:2015 certificates and one ISO 14001:2015 certificate